MEMORANDUM OF UNDERSTANDING
ON CANCER DIAGNOSTIC DEVICES FOR NEAR PATIENT USE
AMONG THE NATIONAL CANCER INSTITUTE, NATIONAL INSTITUTES OF HEALTH, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
AND FOOD AND DRUG ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
AND HEALTH RESOURCES AND SERVICES ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

I. Preamble:

The National Cancer Institute (NCI), the U.S. Food and Drug Administration (FDA), and the Health Resources and Services Administration (HRSA) as part of the Department of Health and Human Services (HHS), and hereinafter referred to as "Federal Partners", agree to work together to facilitate cooperative activities in understanding the molecular biology of cancer as it relates to screening and diagnostic measurements/tools, product development, and therapeutic treatment in accordance with their respective individual missions.

II. Purpose:

This Memorandum of Understanding (MOU) sets forth the basic principles and guidelines under which the Federal Partners intend to foster partnership in research and education; the exchange of ideas, information, and data; in the development and validation of cancer screening and diagnostic devices for near patient use for rural and medically underserved communities in order to detect and diagnose cancer early, improve patient response to treatment, reduce the pain and suffering of cancer and improve the standard of living and quality of life. Generally, near patient diagnostics refers to a system whereby the sample is analyzed, and the results delivered all in the same location and same time that the patient is being evaluated.

To advance the field of cancer diagnostics for near patient use (generally near to, or at the side of, the patient), the Federal Partners would benefit from a discussion of barriers to near patient testing, including but not limited to organizational, technical, analytical, regulatory and provider workflows. A primary purpose of this MOU is to establish an interagency Cancer Diagnostic Devices (CD2) Task Force. The CD2 Task Force will coordinate the Federal Partners' scientific and programmatic collaborations and discuss areas of regulatory and technical challenges to translation and implementation of cancer screening and diagnostic devices for near patient use, in particular, as it pertains to rural and medically underserved communities.

The Federal Partners seek to advance public health and science by enabling and encouraging the sharing of knowledge and supporting the formation of research teams to solve complex problems in the area of each agency’s mission. Through the collaboration described in this MOU, the NCI seeks to enhance information available to the scientific community, including the extramural community, on translating advances in cancer diagnostic devices for near patient use to the marketplace. The collaboration may provide a pathway for FDA to extend its outreach to medical device manufacturers early in the development of those products. The collaboration may provide a pathway for HRSA to improve access to and/or the quality of health care services for rural and medically underserved communities.

III. Background:

The Federal Partners exist and work to protect the public health but have different statutory mandates and responsibilities. The programmatic strengths of the NCI, FDA, and HRSA in the areas of technology development and standardization; analytical validation; clinical trial design; understanding of the needs of health care organizations and providers serving rural and medically underserved communities; and the factors that facilitate adoption and implementation of new technology or clinical interventions in those settings offer a great opportunity for synergy that will accelerate development and translation of cancer screening and diagnostic devices for near patient use.

FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 301 et seq.). FDA is a science-based regulatory agency responsible for protecting the public health through the regulation of food, cosmetics, and medical products, including, but not limited to, human drugs, biological products, animal drugs, and medical devices. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. FDA administers the FD&C Act (see 21 U.S.C. § 321) and relevant sections of the Public Health Service Act (see 42 U.S.C. § 262), among other statutes. Among its duties, FDA reviews and monitors the use of investigative articles in clinical studies, approves pre-market applications, conducts inspections of manufacturing facilities, monitors post-marketing adverse events, and conducts regulatory research. Within FDA, the mission of the Center for Devices and Radiological Health (CDRH) is to protect and promote the public health by assuring that patients and providers have timely and continuous access to safe, effective, and high-quality medical devices and safe radiation-emitting products.

The FDA’s Office of In Vitro Diagnostics and Radiological Health in CDRH’s Office of Product Evaluation and Quality was created to handle all aspects of in vitro diagnostic approval, compliance and quality, and post-market surveillance, to ensure that marketed devices have a reasonable assurance of safety and effectiveness. With the emergence of cancer diagnostic devices for near patient use, the FDA needs to prepare for new regulatory challenges while continuing to apply scientific evidence-based oversight. The FDA Oncology Center of Excellence (OCE) leverages the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics, and devices (including diagnostics). The OCE will help expedite the development of oncology and hematology medical products and support an integrated approach in the clinical evaluation of drugs, biologics, and devices for the treatment of cancer.

The NCI is the Federal government’s principal agency for the conduct and support of research, training, health information dissemination, and other programs related to the cause, prevention, diagnosis, and treatment of cancer; cancer survivorship; and the continuing care of cancer patients and their families, as authorized under Section 410 of the Public Health Service Act (42 U.S.C. § 285). As the leader of the U.S. Federal government’s cancer research enterprise, collectively known as the National Cancer Program, and the largest funder of cancer research in the world, NCI manages a broad range of research, training, and information dissemination activities that reach across the entire country, meeting the needs of all demographics—rich and poor, urban and rural, and all racial and ethnic populations.

HRSA is the primary federal agency for improving health care of people who are geographically isolated, economically or medically vulnerable. Its mission is to improve health outcomes and address health disparities through access to high quality services, a skilled health workforce, and innovative, high-value programs. HRSA programs help those in need of high-quality primary health care, people with HIV, pregnant women, mothers, and families. HRSA also supports the training of health professionals, the distribution of providers to areas where they are needed most and improvements in health care delivery.

IV. Authority:

FDA has authority to enter into this MOU pursuant to sections 1003(b) and (c) of the FD&C Act. NCI has the authority to enter into this MOU in accordance with sections 301, 405, and 410 of the Public Health Service Act. HRSA has the authority to enter into this MOU in accordance with its program management responsibilities under various provisions of the Public Health Service Act, Social Security Act, and other authorizing statutes, as applicable to the specific activity at issue.

V. Responsibilities of the Federal Partners:

Subject to compliance with applicable laws, regulations, and policies, it is mutually agreed that the Federal Partners will cooperate as identified below:

1. Establish an interagency CD2 Task Force.
2. Appoint agency representatives to participate in the CD2 Task Force.
3. Consider future recommendations and/or guidelines to provide updated, relevant information to the public including recipients of NCI, FDA, and HRSA awards, and to support activities related to improving health care for rural and medically underserved communities.
4. Develop joint educational materials to provide updated, relevant information to the public including recipients of NCI, FDA, and HRSA awards, and to support activities related to improving health care in rural and medically underserved communities.
5. Exchange of respective expertise, scientific and technical information, data, and publications across agencies.
6. Appoint representatives from each agency to participate in workshops, working groups, seminars, and other related activities.

A. To pursue the collaboration described above the Federal partners intend to use the following framework for implementing collaborations:

1. The NCI, FDA, and HRSA have identified the Liaison Officers in Section VIII. to implement and manage this MOU. The Liaison Officers intend to meet on a regular basis to discuss activities conducted under the MOU, review all aspects of implementation, and plan future directions of programmatic interaction and cooperation, and report to signatories annually.
2. Concepts or ideas for developing collaborations or activities involving joint projects or integrated approaches to conducting science or technology development and standardization will be formally presented by submission of concepts to the Liaison Officers of the MOU.
3. The collaborative activities contemplated under this MOU may involve additional parties and will be implemented through separate agreements, as needed.

VI. Principles and Procedures for the Sharing of Non-Public Information:

Subject to compliance with applicable laws and regulations, and in accordance with policies, FDA, NCI, and HRSA agree that the following principles and procedures will govern the exchange of data and non-public information among the agencies.

As fellow agencies within HHS, the Federal Partners can generally share information in the possession of either agency with each other, subject to applicable law and authorizations.

Each Federal partner recognizes and acknowledges, however, that all non-public information shared between the Federal Partners, whether in writing or orally, cannot be further shared unless authorized by law. See, e.g., 18 U.S.C. § 1905; 5 U.S.C. § 552 and 552a; 21 U.S.C. § 331(j) and 360j(c); 21 CFR Parts 20 and 21; 42 U.S.C. § 241(d); 45 CFR Parts 5 and 5b. Safeguards are needed to protect shared non-public information, such as trade secrets and confidential commercial information; identities of study participants and other personal privacy information; privileged and/or pre-decisional agency information; research proposals, progress reports, and/or unpublished data; or national security information. Such safeguards also help ensure compliance by the Federal Partners with other applicable laws and regulations. The sharing of identifiable patient information and national security information is not contemplated by this MOU.

To facilitate the sharing of non-public information, written or oral, the Federal Partners shall implement procedures to ensure that such sharing is appropriate and in accordance with applicable law, and that the Federal partner receiving non-public information (Requesting Federal Partner) will guard the confidentiality of all non-public information received.¹ The Federal Partners are committed to responding to requests for information in a complete and timely manner, consistent with budgetary and resource constraints, and in accordance with applicable laws, regulations, and agency policy and practice.

The provisions for sharing of non-public information in accordance with applicable laws, regulations, and agency policy and practice are set out below:

1. The Requesting Federal Partner must specify, in writing, the information requested (to facilitate identification of relevant information), provide a brief statement of why the information is needed, and include the following requesting party template language: “This request is made pursuant to the Memorandum of Understanding on Point-of-Care Diagnostics in Early Detection & Screening of Cancer among FDA, NCI and HRSA, dated [insert date of request]. [insert name of Requesting Federal Partner] agrees not to disclose any non- public information shared between [insert name of Requesting and Sharing Federal Partners] whether orally or in writing, in any manner.”
2. The Federal Partner that is considering sharing information (Sharing Federal Partner) will first determine what should be shared, review the information to be shared and identify whether any of this information is non-public. The Sharing Federal Partner will also determine whether sharing the information is consistent with all applicable laws, regulations, and policies. If non-public information has been identified, the Sharing Federal Partner will clearly label the relevant materials as follows: “This document contains non-public information. Do not disclose without permission of [insert name of Sharing Federal Partner].”
3. The Requesting Federal Partner must promise in writing that it will not further disseminate the shared non-public information without permission of the Sharing Federal Partner or as required by law. The promise can be accomplished through a written letter, e.g., email. A model promise letter is attached. Upon mutual agreement, the Federal Partners may modify the promise letter appropriately, e.g., to permit the sharing of related non-public information over a specified period of time.

The Requesting Federal Partner will comply with the following conditions:

1. The Requesting Federal Partner will limit the dissemination of shared non- public information it receives to internal Federal Partner offices and/or employees that have been identified in its written request who have a need to know. If the Requesting Federal Partner determines that employees other than those identified in the original request have a need to know the requested information, then an update to the request letter will be supplied to the Sharing Federal Partner before the Requesting Federal Partner distributes the information to those employees. The Federal Partner official who signs the request letter will be responsible for ensuring that there are no inappropriate recipients of the information.
2. If the Requesting Federal Partner receives a FOIA request for shared information, the Requesting Federal Partner will: (a) if the request implicates documents from the Sharing Federal Partner in their original form, refer the FOIA request to the Sharing Federal Partner to respond directly to the FOIA requester regarding the release of the information, and notify the FOIA requester of the referral and that a response will issue directly from the Sharing Federal Partner; or (b) if the request implicates documents authored by the Receiving Federal Partner that incorporates information from shared documents, consult with the Sharing Federal Partner about how to respond to the FOIA request. The Requesting Federal partner will not indicate to the FOIA requester whether the Sharing Federal Partner has responsive records or releasable records. All actions taken under this paragraph must be in compliance with 45 C.F.R. 5.25.
3. The Sharing Federal Partner will include a transmittal letter along with any agency non-public information shared. The transmittal letter will indicate the type of information (e.g., confidential commercial information, personal privacy, pre-decisional, etc.). A model transmittal letter is attached. The shared documents containing non-public information should state “This document contains non-public information. Do not disclose without permission of [Sharing Federal Partner]”, as applicable.
4. The Requesting Federal Partner will promptly notify the contact person or designee of the Sharing Federal Partner of any attempt by a third party to obtain shared non-public information by processes, including, but not limited to, a FOIA request, judicial order, subpoena, discovery request, or litigation complaint or motion.
5. The Requesting Federal Partner will notify the Sharing Federal Partner before complying with any request that compels the release of shared non- public information, so that the Federal Partners may determine the appropriate measures to take, including, where appropriate, legal action.

VII. General Provisions:

1. All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and funds. No funds are obligated or otherwise committed by this MOU.
2. This MOU does not affect or supersede any existing or future agreements or arrangements among the Federal Partners, and does not affect the ability of the Federal Partners to enter into other agreements or arrangements related to this MOU.
3. This MOU and all associated agreements will be subject to the applicable laws, regulations and policies under which FDA, NCI, and HRSA operate.

VIII. Liaison Officers:

For FDA:

Wendy Rubinstein, M.D., Ph.D.
Director, Personalized Medicine
Center for Devices and Radiological Health
OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality
U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993, USA
Tel: 240-402-7070
Email: [email protected]

Živana Težak, Ph.D.
Associate Director for Science and Technology
OHT7: In Vitro Diagnostics and Radiological Health OIR Office of Product Evaluation and Quality
Center for Devices and Radiological Heath
U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993, USA
Tel: 301-796-6206; Cell 301-980-2169
Email: [email protected]

Julie A. Schneider, Ph.D.
Associate Director for Research Strategy and Partnerships Oncology Center of Excellence
U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993, USA
Tel: 240-402-4658; Cell: 240-338-7723
Email: [email protected]

For NCI:

Christopher M. Hartshorn, Ph.D. Program Director
Division of Cancer Treatment and Diagnosis National Cancer Institute
National Institutes of Health
9609 Medical Center Drive, RM 4W220 Rockville, MD 20850, USA
Tel: 240-781-3315
Email: [email protected]

Sonia M. Rosenfield, Ph.D. Health Science Administrator
Epidemiology and Genomics Research Program Division of Cancer Control and Populations Sciences National Cancer Institute
National Institutes of Health
9609 Medical Center Drive, RM 4E304 Rockville, MD 20850, USA
Tel: 301-605-3521
Email: [email protected]

Ashim Subedee, Ph.D. Academic Innovation Lead
Small Business Education and Entrepreneurial Development Office of Extramural Research
National Institutes of Health 9000 Rockville Pike Bethesda, MD 20892, USA Tel: 301-594-9747
Email: [email protected]

Robin C. Vanderpool, DrPH Branch Chief
Health Communication and Informatics Research Division of Cancer Control and Populations Sciences National Cancer Institute
National Institutes of Health
9609 Medical Center Drive, RM 3E610 Rockville, MD 20850, USA
Tel: 301-276-6558
Email: [email protected]

Henry Rodriguez, Ph.D., M.S., M.B.A.
Director, Office of Cancer Clinical Proteomics Research Division of Cancer Treatment and Diagnosis
National Cancer Institute National Institutes of Health 31 Center Drive, MSC 2580 Bethesda, MD 20892, USA Tel: 240-781-3370
Email: [email protected]

For HRSA:

Sabrina Matoff-Stepp, Ph.D. Senior Advisor
Office of Planning, Analysis, and Evaluation Health Resources and Services Administration 5600 Fishers Lane
Rockville MD 20850 USA Tel: 301-443-8664
Email: [email protected]

IX. Term, Termination, and Modification:

This MOU becomes effective on the date of latest signature and will remain in effect for 5 years, or until terminated by any Federal Partner upon a ninety (90) day advance written notice to the other Federal Partners. This MOU may be modified in writing by unanimous consent of the Federal Partners.

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APPROVED AND ACCEPTED FOR NATIONAL CANCER INSTITUTE

/s/
Norman E. Sharpless, M.D. Director, National Cancer
Institute, National Institutes of Health
Date: 6/9/2021

APPROVED AND ACCEPTED FOR FOOD AND DRUG ADMINISTRATION

/s/
Jeffrey E. Shuren, M.D., J.D.
Director, Center for Devices and Radiological Health
U.S. Food and Drug Administration
Date: 6/7/2021

/s/
Richard Pazdur, M.D.
Director, Oncology Center of Excellence
U.S. Food and Drug Administration
Date: 6/8/2021

APPROVED AND ACCEPTED FOR HEALTH RESOURCES AND SERVICES ADMINISTRATION

/s/
Susan Monarez, Ph.D.
Director, Office of Planning, Analysis, and Evaluation
Health Resources and Services Administration
Date: 6/8/2021

Appendix A: Model Language for Information Request

The [National Cancer Institute (NCI)/Health Resources and Services Administration (HRSA)/Food and Drug Administration (FDA)] has requested the following information from the [National Cancer Institute (NCI)/Health Resources and Services Administration (HRSA)/Food and Drug Administration (FDA)] for the following purposes: [Identify information and purpose]

Or

[NCI/HRSA/FDA] hereby requests the following information from [NCI/HRSA/FDA] for the following purposes: [Identify information and purpose]

Upon receipt of designated non-public information shared by [NCI/HRSA/FDA], [NCI/HRSA/FDA] agrees that it will not disclose to any other party any such information that [NCI/HRSA/FDA] shares without prior written permission from [NCI/HRSA/FDA] and that it will comply with the principles and procedures set forth in the Memorandum of Understanding on Cancer Diagnostic Devices for Near Patient Use between NCI, FDA, and HRSA. [NCI/HRSA/FDA] acknowledges that applicable statutes and regulations may prohibit the further disclosure of such information. See, e.g., 5 U.S.C. sec. 552; 5 U.S.C. sec. 552a, 21 U.S.C. sec. 331(j) and 360j(c), 18 U.S.C. sec. 1905, 21 C.F.R. Parts 20 and 21, 45 C.F.R. Parts 5 and 5b and 42 U.S.C. sec. 241(d).

[NCI/HRSA/FDA] will limit dissemination of any shared non-public information to the following [NCI/HRSA/FDA] offices and/or employees, unless it identifies additional [NCI/HRSA/FDA] employees who have a need to know the non-public information: [Identify office(s) and/or employee(s)]

Model Transmittal Letter

This letter accompanies and must be retained with the information that the [NCI/HRSA/FDA] is sharing with the [NCI/HRSA/FDA] in response to [NCI/HRSA/FDA’s] request, dated. This information contains one or more of the following categories of non-public information, including information the public disclosure of which may be prohibited by law;

[NCI/HRSA/FDA checks applicable items below]

            Trade secrets;
            Confidential commercial or financial information;
            Information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy;
            Information subject to the Privacy Act;
            Privileged or pre-decisional agency information;
            Information contained in inter-agency or intra-agency memoranda;
            Records or information compiled for law enforcement purposes; or
            Other.

[NCI/HRSA/FDA] shall notify the appropriate liaison officer of [NCI/HRSA/FDA] if there are any attempts to obtain shared information by compulsory process, including but not limited to, Freedom of Information Act requests, subpoenas, judicial orders, discovery requests, and litigation complaints or motions.

[NCI/HRSA/FDA] shall notify [NCI/HRSA/FDA] before complying with any judicial order that compels the release of such information so that [NCI/HRSA/FDA] may take appropriate measures, including filing a motion with the court or an appeal.

[NCI/HRSA/FDA] has agreed, by this letter or e-mail and by a signed request letter dated
                                      , not to publicly disclose the above-described information without prior written permission of [NCI/HRSA/FDA]. [NCI/HRSA/FDA] acknowledges that applicable laws and regulations may govern the disclosure of such information. See, e.g., 5 U.S.C. sections 552 and 552a; 21 U.S.C. section 331(j) and 360j(c); 18 U.S.C. section 1905, 21 C.F.R. Parts 20 and 21, 45 CF.R. Parts 5 and 5b and 42 U.S.C. Section 241(d).

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¹ Each Federal Partner has implemented or will implement its respective agency’s data and information security statutory, regulatory, or procedural requirements and has implemented or will implement, to the extent necessary and practicable, all data and information security recommendations suggested by the other agencies. See Appendix A for Model Language.